FDA Registration
Active
🇫🇷 France
P.L.U.S. System (Pivot Link Universal System)
Reg #: 3003526896
·
FEI: 3003526896
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- SPINEVISION SAS
- Registration Number
- 3003526896
- FEI Number
- 3003526896
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3 Rue De La Renaissance
- City
- Antony Hauts-de-Seine
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K022271
Owner / Operator
- Firm Name
- SPINEVISION SAS
- Operator Number
- 9048013
- Address
- 3 rue de la Renaissance
- City
- Antony
- State
- Paris
- Postal Code
- F-92160
- Country
- FR
- Correspondent
- Quang TRAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-07-17 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-07-17 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-07-17 |
Proprietary Names
P.L.U.S. System (Pivot Link Universal System)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device